Multiple SclerosisNCT01758224
Expiratory Muscle Conditioning in Multiple Sclerosis Using Magnetic Stimulation
A study testing Functional Magnetic Stimulation and Resistive Expiratory Muscle Training in people with Multiple Sclerosis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Multiple sclerosis (MS) is a primary disorder of the central nervous system that may affect motor pathways and cause muscle weakness. Respiratory complications due to respiratory muscle weakness are common in the terminal stages of MS and contribute to mortality in these patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Functional Magnetic Stimulation and Resistive Expiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple Sclerosis diagnosis
- Baseline maximal expiratory pressure (MEP) values between 50% and 70% of predicted values
- Patients must also be in stable condition and free of active brain disease or cardiovascular disorders (history of myocardial infarction, congestive heart disease, or uncontrolled hypertension).
Who cannot join
- Cardiac pacemakers, ferromagnetic metal implants, uncontrolled high blood pressure, active pulmonary conditions such as chronic obstructive pulmonary disease, bronchiectasis, asthma, and diaphragmatic paralysis.
- Patients who are ventilator dependent, with significant scoliosis, other chest wall deformity, obesity, severe diabetes mellitus, as well as pregnant women will be excluded from participating in the study.
- Patients with substance abuse or mental incompetence will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cleveland Clinic Research Program: Expiratory Muscle Conditioning Using Functional Magnetic Stimulation for Patients With Multiple Sclerosis
Multiple sclerosis (MS) is a primary disorder of the central nervous system that may affect motor pathways and cause muscle weakness. Respiratory complications due to respiratory muscle weakness are common in the terminal stages of MS and contribute to mortality in these patients. Respiratory muscle weakness may also impair the performance of coughing and aspiration, pneumonia, or even acute ventilatory failure may ensue. Functional magnetic stimulation (FMS) is a non-invasive method that promotes the contraction of muscles through nerve activation. Over the last few years, the study investigators have demonstrated efficacy of FMS technology for stimulating respiratory muscles in animal models, able-bodied subjects [3] and spinal cord injured (SCI) patients [4]. In this study, the researchers will investigate the efficacy of using FMS technique for respiratory muscle conditioning in patients with MS. Furthermore, the investigators will also compare expiration related outcomes of FMS technique with resistive expiratory muscle training (REMT) methodology.
Hypotheses
- FMS conditioning of the expiratory muscles can generate significant expiratory flows and pressures in patients with MS.
- FMS conditioning of expiratory muscles is more effective compared to resistive expiratory muscle training (REMT) in patients with MS.
Read the detailed description
Optimal respiratory function depends on intact neural circuitry which orchestrates the interplay between respiratory muscles and intrinsic pulmonary function to maintain adequate ventilation. In the absence of respiratory muscle activation, pressure gradients cannot be developed and air exchange at the alveolar surface cannot occur. Thus, any impairment in respiratory muscle performance can lead to pulmonary dysfunction, respiratory distress and even death. Multiple sclerosis (MS) is a primary disorder of the central nervous system that often affects motor pathways, causing diminished muscle strength and endurance throughout the body including the ventilatory muscles. Respiratory complications are recognized as the major cause of morbidity and mortality in individuals with advanced MS. The investigators' research team has over 15 years of experience using Functional Magnetic Stimulation (FMS) for stimulating nerves and muscles below the level of injury in patients with chronic SCI; and has also demonstrated significant benefit for improving respiratory muscles, bladder and bowel functions. In this study, the investigators will investigate the efficacy of using FMS technique for respiratory muscle conditioning in patients with multiple sclerosis; and will compare the results of the expired functions (volume, pressure, and flow) generated by using the FMS technique with data obtained from using the resistive expiratory muscle training (REMT) methodology.
- Conditions
- Multiple Sclerosis
- Being tested
- Functional Magnetic Stimulation, Resistive Expiratory Muscle Training
- Keywords
- Multiple Sclerosis, Functional Magnetic Stimulation, Pulmonary Function
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic StimulationOther
Also called FMS
The magnetic stimulation protocol (plan of study) consists of a daily expiratory (breathing out) muscle conditioning program (20 minutes). A magnetic coil will be placed on participant's back to stimulate the nerves related to the breathing function. Each stimulation will last two seconds and the time between each stimulation is about half a minute. The training session will begin with low intensity FMS for 20 minutes daily. The FMS stimulation intensity will gradually increase during the 6-week training period.
Resistive Expiratory Muscle TrainingOther
Also called REMT
The REMT training will take place in the FMS lab using a standard resistive breathing device. After training, participants will perform the exercise for 20 minutes daily (5days each week for 6 weeks) in their home. Participants will wear a nose clip when performing the breathing exercise. The exercise protocol will begin with a low resistance level for 20 minutes a day. The resistance level will gradually increase during the 6-week training period.
| Study group | Role | What they receive |
|---|---|---|
| Functional Magnetic Stimulation | Experimental | This group will receive magnetic stimulation of the respiratory (breathing) muscles that may improve the breathing function in subjects with MS. The magnetic stimulation protocol (plan of study) consists of a daily expiratory (breathing out) muscle conditioning program (20 minutes). Receives: Other: Functional Magnetic Stimulation |
| Resistive Expiratory Muscle Training | Active comparator | Participants in this group will perform breathing exercises using a resistive breathing device. The training will take place in the FMS lab. After training, participants will perform the exercise for 20 minutes daily (5days each week for 6 weeks) in their home. Receives: Other: Resistive Expiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Testing (PFT)
Changes in participant's pulmonary (lung) function will be assessed using a non-invasive pulmonary function test (PFT).
Measured: At study initiation and every two weeks over a 14 week period (8 PFTs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Vernon W Lin, MD PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758224
- Sponsor's protocol ID
- W81XWH-11-1-0707
- Status last verified
- Aug 2016
- First submitted
- 19 Dec 2012
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lin VW, Hsiao IN, Zhu E, Perkash I. Functional magnetic stimulation for conditioning of expiratory muscles in patients with spinal cord injury. Arch Phys Med Rehabil. 2001 Feb;82(2):162-6. doi: 10.1053/apmr.2001.18230.
PubMed 11239305Singh H, Magruder M, Bushnik T, Lin VW. Expiratory muscle activation by functional magnetic stimulation of thoracic and lumbar spinal nerves. Crit Care Med. 1999 Oct;27(10):2201-5. doi: 10.1097/00003246-199910000-00022.
PubMed 10548207
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cleveland Clinic Research Program: Expiratory Muscle Conditioning Using Functional Magnetic Stimulation for Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01758224
- Acronym / sponsor ID
- W81XWH-11-1-0707
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Functional Magnetic Stimulation, Pulmonary Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple sclerosis (MS) is a primary disorder of the central nervous system that may affect motor pathways and cause muscle weakness. Respiratory complications due to respiratory muscle weakness are common in the terminal stages of MS and contribute to mortality in these patients. Respiratory muscle weakness may also impair the performance of coughing and aspiration, pneumonia, or even acute ventilatory failure may ensue. Functional magnetic stimulation (FMS) is a non-invasive method that promotes the contraction of muscles through nerve activation. Over the last few years, the study investigators have demonstrated efficacy of FMS technology for stimulating respiratory muscles in animal models, able-bodied subjects [3] and spinal cord injured (SCI) patients [4]. In this study, the researchers will investigate the efficacy of using FMS technique for respiratory muscle conditioning in patients with MS. Furthermore, the investigators will also compare expiration related outcomes of FMS technique with resistive expiratory muscle training (REMT) methodology.
Hypotheses
- FMS conditioning of the expiratory muscles can generate significant expiratory flows and pressures in patients with MS.
- FMS conditioning of expiratory muscles is more effective compared to resistive expiratory muscle training (REMT) in patients with MS.
Detailed description
Optimal respiratory function depends on intact neural circuitry which orchestrates the interplay between respiratory muscles and intrinsic pulmonary function to maintain adequate ventilation. In the absence of respiratory muscle activation, pressure gradients cannot be developed and air exchange at the alveolar surface cannot occur. Thus, any impairment in respiratory muscle performance can lead to pulmonary dysfunction, respiratory distress and even death. Multiple sclerosis (MS) is a primary disorder of the central nervous system that often affects motor pathways, causing diminished muscle strength and endurance throughout the body including the ventilatory muscles. Respiratory complications are recognized as the major cause of morbidity and mortality in individuals with advanced MS. The investigators' research team has over 15 years of experience using Functional Magnetic Stimulation (FMS) for stimulating nerves and muscles below the level of injury in patients with chronic SCI; and has also demonstrated significant benefit for improving respiratory muscles, bladder and bowel functions. In this study, the investigators will investigate the efficacy of using FMS technique for respiratory muscle conditioning in patients with multiple sclerosis; and will compare the results of the expired functions (volume, pressure, and flow) generated by using the FMS technique with data obtained from using the resistive expiratory muscle training (REMT) methodology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Magnetic Stimulation | Experimental | Other: Functional Magnetic StimulationThis group will receive magnetic stimulation of the respiratory (breathing) muscles that may improve the breathing function in subjects with MS. The magnetic stimulation protocol (plan of study) consists of a daily expiratory (breathing out) muscle conditioning program (20 minutes). |
| Resistive Expiratory Muscle Training | Active comparator | Other: Resistive Expiratory Muscle TrainingParticipants in this group will perform breathing exercises using a resistive breathing device. The training will take place in the FMS lab. After training, participants will perform the exercise for 20 minutes daily (5days each week for 6 weeks) in their home. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Multiple Sclerosis diagnosis
- Baseline maximal expiratory pressure (MEP) values between 50% and 70% of predicted values
- Patients must also be in stable condition and free of active brain disease or cardiovascular disorders (history of myocardial infarction, congestive heart disease, or uncontrolled hypertension).
Key exclusion criteria (3 listed)
- Cardiac pacemakers, ferromagnetic metal implants, uncontrolled high blood pressure, active pulmonary conditions such as chronic obstructive pulmonary disease, bronchiectasis, asthma, and diaphragmatic paralysis.
- Patients who are ventilator dependent, with significant scoliosis, other chest wall deformity, obesity, severe diabetes mellitus, as well as pregnant women will be excluded from participating in the study.
- Patients with substance abuse or mental incompetence will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Magnetic StimulationAlso: FMSThe magnetic stimulation protocol (plan of study) consists of a daily expiratory (breathing out) muscle conditioning program (20 minutes). A magnetic coil will be placed on participant's back to stimulate the nerves related to the breathing function. Each stimulation will last two seconds and the time between each stimulation is about half a minute. The training session will begin with low intensity FMS for 20 minutes daily. The FMS stimulation intensity will gradually increase during the 6-week training period. | Other | Functional Magnetic Stimulation |
| Resistive Expiratory Muscle TrainingAlso: REMTThe REMT training will take place in the FMS lab using a standard resistive breathing device. After training, participants will perform the exercise for 20 minutes daily (5days each week for 6 weeks) in their home. Participants will wear a nose clip when performing the breathing exercise. The exercise protocol will begin with a low resistance level for 20 minutes a day. The resistance level will gradually increase during the 6-week training period. | Other | Resistive Expiratory Muscle Training |
Primary outcome
Pulmonary Function Testing (PFT)
Time frame: At study initiation and every two weeks over a 14 week period (8 PFTs)
Changes in participant's pulmonary (lung) function will be assessed using a non-invasive pulmonary function test (PFT).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Background: PubMed 11239305Lin VW, Hsiao IN, Zhu E, Perkash I. Functional magnetic stimulation for conditioning of expiratory muscles in patients with spinal cord injury. Arch Phys Med Rehabil. 2001 Feb;82(2):162-6. doi: 10.1053/apmr.2001.18230.
- Background: PubMed 10548207Singh H, Magruder M, Bushnik T, Lin VW. Expiratory muscle activation by functional magnetic stimulation of thoracic and lumbar spinal nerves. Crit Care Med. 1999 Oct;27(10):2201-5. doi: 10.1097/00003246-199910000-00022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vernon W Lin, MD PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Magnetic Stimulation and Resistive Expiratory Muscle Training in people with Multiple Sclerosis, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Testing (PFT) (time frame: At study initiation and every two weeks over a 14 week period (8 PFTs)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01758224, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016; AzTrials last refreshed its copy on 3 Nov 2026.